Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136448
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2005-08-25
Brief Title:
High Dose Ara-C HDAC and Interleukin-2 IL-2 for Patients With Acute Myelogenous Leukemia AML
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will add interleukin-2 IL-2 to a regimen of post-remission therapy consisting of high-dose ara-C Patients with AML in first remission will receive 3 cycles of high-dose ara-C followed by continuous infusion and bolus interleukin-2 IL-2 We the researchers at the Dana-Farber Cancer Institute plan to evaluate the immunologic effects of such treatment in these patients
Detailed Description:
Patients will receive standard remission induction therapy with daunorubicin at a dose of 45 mgm2day for 3 days and continuous infusion cytarabine at a dose of 200 mgm2day for 7 days
Those patients who enter a remission status and have preserved liver and kidney function will then receive 3 cycles of post-remission therapy that will consist of high-dose cytarabine at a dose of 3000 mgm2 every 12 q12 hours on days 1 3 and 5 total of 6 doses
Patients who are still in remission will receive interleukin-2 IL-2 upon count recovery at a dose of 81 X 105 Um2day by continuous infusion for 10 weeks In addition patients will receive bolus IL-2 at a dose of 6 X 105 Um2 by intravenous bolus weekly for 6 doses through day 63
Patients will be seen on a weekly basis while on treatment for examination and bloodwork
At the end of treatment patients will have a physical exam and bloodwork performed monthly for two years then 4 times per year for two years
Those patients who enter a remission status and have preserved liver and kidney function will then receive 3 cycles of post-remission therapy that will consist of high-dose cytarabine at a dose of 3000 mgm2 every 12 q12 hours on days 1 3 and 5 total of 6 doses
Patients who are still in remission will receive interleukin-2 IL-2 upon count recovery at a dose of 81 X 105 Um2day by continuous infusion for 10 weeks In addition patients will receive bolus IL-2 at a dose of 6 X 105 Um2 by intravenous bolus weekly for 6 doses through day 63
Patients will be seen on a weekly basis while on treatment for examination and bloodwork
At the end of treatment patients will have a physical exam and bloodwork performed monthly for two years then 4 times per year for two years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None